FDA Policy/General

Gottlieb Worried About RFK Jr. Pick for HHS

Former FDA Commissioner Scott Gottlieb (Trump Administration’s first term) is predicting a difficult hurdle for Robert F. Kennedy Jr. to win Senate confirmation as HHS secretary due to his extreme vaccine hesitancy stance. Gottlieb said this during an 11/29 appearance on CNBC’s “Squawk Box,” where he also praised the credentials of Trump’s picks to lead FDA and the Centers for Medicare and Medicaid Services, Marty Makary and Mehmet Oz, respectively. He said he knew Makary and he was a good selection for FDA, and he noted Oz could be a “transformative” pick to lead CMS and would be a good fit to lead health and wellness priorities for seniors, who grew up watching him on television.

“I think if RFK falls through on his intentions, and I believe he will, and I believe he can, it will cost lives in this country,” Gottlieb said, adding that measles, mumps and rubella vaccination rates will go down. “For every 1,000 cases of measles that occur in children, there will be one death, and we are not good in this country at diagnosing and treating measles,” he said.

Gottlieb said he has already had conversations with some senators and others in Trump’s orbit about RFK Jr. “Look, I think that there's skepticism in the Republican caucus more than I think the press is reporting right now,” he continued. “There’s going to be [agriculture] state senators that are concerned about his impact on food prices. There’s going to be principled pro-lifers who are concerned about his positions on abortion. There’s going to be a number of public health-minded senators who have deep concerns about his position on vaccines.”

Regarding Trump’s position on the extreme measures RFK Jr. promotes, Gottlieb said he did not think that these policy efforts reflect the president-elect’s views as well. “I don't think the president wants to see a resurgence of measles, wants to see a resurgence of whooping cough in this country,” he said. “God forbid we have cases of polio in this country. He does not want to see that. I think he understood the importance of the childhood immunization schedule.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome